Reaction Product of Rosin, fumarated, Tall-Oil Rosin, Ca(OH)2 and MgO

Endpoint summary

Description of key information

Based on the results of in vitro investigations Ca/Mg-salt of Fumarated Tall OIL Rosin is considered to have skin irritating property but is predicted as non-irritant in the Human Corneal Epithelial Model 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

SKIN CORROSION / IRRITATION

An in-vitro study for predicting non-specific, corrosive potential of Ca/Mg-salt of Fumarated Tall Oil Rosin by using reconstructed human skin (RHS) EST-1000 in accordance with OECD TG 431 and with an EC guideline (amending Concil Direcrive 67/548/EEC B 40 Skin corrosion).

Ca/Mg-salt of Fumarated Tall OIl Rosin was tested undissolved (25 mg per insert, plus 50 µl 0.9 % NaCl to moisten and to ensure good contact with the skin) and an incubation time of 3 min or of 60 min was used to determine time related toxic effects. After incubation the MTT reduction assay was performed to measure the cell viability which was 98 % and 112 % (rounded), respectively. Thus, the results show that no corrosive property of the test item was determined by the assay used (Bayer Pharma AG 2011)

The study which allows the hazard identification of irritant substances in accordance with GHS category 2, was performed in 2011. The experiment was carried out according to OECD 439 and EU Test Method B.46 using commercially available reconstructed human epidermis (RHS) model EST-1000 (CellSystems, St.Katharinen, Germany).

Undissolved Ca/Mg-salt of Fumarated Tall Oil Rosin was applied topically to the RHS model, i.e. 30 mg per insert (plus 30µl 0.9% NaCl to moisten and ensure good contact with the skin; three replicates). After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured to be 29 % (rounded) in the MTT (Methylthiazoletetrazolium) conversion assay. The results of the concurrent negative control (NC, 0.9% NaCl) and positive control (PC, 5% SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.

In a primary dermal irritation study with Fumarated tall oil resin, six young adult New Zealand white rabbits were exposed to 0.5 g of rosin, fumarated applied for 4 hours under semi-occluded contact to intact skin (Life Science Research, 1991b). Methods used in this study were compliant with current guidelines (OECD 404). Animals were then observed for a period of 72 hours post-treatment. Irritation was scored. Mean erythema and edema scores for 24 to 72 hours were observed 0 in intact rabbit skin exposed to the test material under semi-occluded contact for 4 hours. Based on these findings, rosin, fumarated was not considered to be a skin irritant to rabbits, and presents a low skin irritation hazard. 

Thus, the results show that Ca/Mg-salt of Fumarated Tall Oil Rosin is more irritant that the educt Fumarated Tall Oil Rosin (FTOR). This is explainable by structural differences. FTOR contains the free acids, which are considered to be weak acids. Salts of these acids with medium strong base Ca and Mg hydroxide are medium strong bases. Thus, Ca/Mg TOR is considered

to have skin irritation effects. (Bayer Phaerma AG 2011). EYE IRRITATION.

This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2011. The model used is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE); SkinEthic, France).

Undissolved Ca/Mg-salt of Fumarated Tall Oil Resin was applied topically to the HCE tissue, i.e. 30 mg per insert (three replicates). After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 113% (rounded) as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control

(PC, 1H-1,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

The results show that Ca/Mg-salt of Fumarated Tall Oil Resin is predicted as non-irritant under the conditions of this test method (Bayer Pharma AG 2011).

Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Based on the available data Ca/Mg-salt of Fumarated Tall Oil Resin has to be grouped to category 2 (H315) for irritating substances according to Regulation(EC)1272 (GHS), 2008 .